Breast CancerNCT04666805
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
An observational study of Breast Cancer, run by First Hospital of China Medical University at 1 site in China.
Trial summary
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen, Toremifene and Anastrozole
- Type of treatment
- Pill or oral medicine
- How many people
- 1,354 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with hormone receptor-positive ductal carcinoma of the breast
Who may be able to join
- (1)Female patients aged ≥ 18 years and ≤ 85 years
- (2)The primary lesions and lymph nodes of the breast must meet all of the following conditions:
- Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range ≤ 1 mm;
- Have received radical resection or breast conserving surgery;
- Patients who have received breast conserving surgery must undergo pathological examination to confirm there is no residual cancer tissue on the cutting edge and receive postoperative radiotherapy within the prescribed dose and range;
- No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination;
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- Immuno
- Immunohistochemical staining results are positive for estrogen receptor (ER) or progesterone receptor (PR), which is defined as ER or PR immunoreactivity intensity ≥1+ or expression percentage ≥ 1%.
- (3)A volunteer to participate in the study and willing to cooperate with follow-up
Who cannot join
- (1)Patients with newly diagnosed metastatic breast cancer or other malignant tumors without breast intraductal carcinoma;
- (2) Patients who have other malignant tumors before the initial diagnosis of intraductal carcinoma of the breast
- (3) Patients who have received endocrine therapy with drugs including Toremifene, Tamoxifen, Anastrozole, Letrozole or Exemestane before the initial diagnosis of intraductal carcinoma of the breast
- (4) Patients who have a serious comorbidity or other comorbidities that interfere with the conduct of the study, or those who are considered not suitable for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
Read the detailed description
Intraductal carcinoma of the breast accounts for 20% of newly diagnosed breast cancer. In addition to necessary surgical treatment, 5-year endocrine therapy is also essential for patients with hormone receptor positive ductal carcinoma of the breast. Commonly used drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Exemestane, Anastrozole, Letrozole). Although these drugs can effectively reduce the recurrence and metastasis of ductal carcinoma of the breast, the adverse reactions of the above drugs significantly reduce the quality of life and treatment compliance of the patients. Therefore, the choice of endocrine therapy for intraductal carcinoma of the breast has been widely discussed. Is it possible for de-escalation of endocrine treatment intensity to reduce adverse reactions and improve patient compliance? Recently, a phase 3 clinical trial found that compared with placebo group, the adverse reactions of Tamoxifen group treated with 5 mg/d (conventional dose 20 mg/d) Tamoxifen for 3 years had less adverse reactions and achieved significant efficacy. This study revealed the reliable efficacy and safety of Tamoxifen, a low-dose drug for treatment of hormone receptor positive intraductal carcinoma of the breast. However, little is reported on the reasonable duration of Aromatase inhibitors for endocrine therapy in patients with intraductal carcinoma of the breast.
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Toremifene, Anastrozole, Letrozole, Exemestane
- Keywords
- breast cancer, hormone receptor, aromatase inhibitor, recurrence, metastasis
- Medical subject headings
- Breast Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
20 mg/d, oral administration
ToremifeneDrug
60 mg/d, oral administration
AnastrozoleDrug
1 tablet (1 mg) per day, oral administration
LetrozoleDrug
Adjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage.
ExemestaneDrug
The recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses.
| Study group | Role | What they receive |
|---|---|---|
| Drug Group | Endocrine therapy drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Anastrozole, Letrozole, Exemestane), which have been widely used in the adjuvant treatment of hormone receptor positive breast cancer. Receives: Drug: Tamoxifen; Drug: Toremifene; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival up to 16 years
Disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which relevant event occurs.
Measured: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Invasive disease-free survival up to 16 years
Invasive disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which intraductal carcinoma of the breast recurs. The recurrent diseases include ipsilateral or contralateral breast cancer, local and distant recurrence of breast cancer, and death due to any reason.
Measured: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Distant disease-free survival up to 16 years
Distant disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which distant metastasis occurs.
Measured: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Secondary outcomes (1)
Overall survival up to 16 years
Overall survival refers to the first disease-free day to the time of death caused by any reason.
Measured: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Jul 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Second Hospital of Jilin University, Jilin Provincial Tumor Hospital, Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, The Second Affiliated Hospital of Dalian Medical University, Shenyang Fifth People's hospital, General Hospital of Benxi Iron and Steel Co., Affiliated Hospital of Hebei University of Engineering, Fourth People's Hospital of Shenyang
- Responsible party
- Principal investigator, Bo Chen, First Hospital of China Medical University
- Investigators
- Bo Chen, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666805
- Sponsor's protocol ID
- FirstHCMU_CB_001
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study
- ClinicalTrials.gov ID
- NCT04666805
- Acronym / sponsor ID
- FirstHCMU_CB_001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, hormone receptor, aromatase inhibitor, recurrence, metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,354 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Second Hospital of Jilin University, Jilin Provincial Tumor Hospital, Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, The Second Affiliated Hospital of Dalian Medical University, Shenyang Fifth People's hospital, General Hospital of Benxi Iron and Steel Co., Affiliated Hospital of Hebei University of Engineering, Fourth People's Hospital of Shenyang
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
Detailed description
Intraductal carcinoma of the breast accounts for 20% of newly diagnosed breast cancer. In addition to necessary surgical treatment, 5-year endocrine therapy is also essential for patients with hormone receptor positive ductal carcinoma of the breast. Commonly used drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Exemestane, Anastrozole, Letrozole). Although these drugs can effectively reduce the recurrence and metastasis of ductal carcinoma of the breast, the adverse reactions of the above drugs significantly reduce the quality of life and treatment compliance of the patients. Therefore, the choice of endocrine therapy for intraductal carcinoma of the breast has been widely discussed. Is it possible for de-escalation of endocrine treatment intensity to reduce adverse reactions and improve patient compliance? Recently, a phase 3 clinical trial found that compared with placebo group, the adverse reactions of Tamoxifen group treated with 5 mg/d (conventional dose 20 mg/d) Tamoxifen for 3 years had less adverse reactions and achieved significant efficacy. This study revealed the reliable efficacy and safety of Tamoxifen, a low-dose drug for treatment of hormone receptor positive intraductal carcinoma of the breast. However, little is reported on the reasonable duration of Aromatase inhibitors for endocrine therapy in patients with intraductal carcinoma of the breast.
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Group | – | Drug: Tamoxifen, Drug: Toremifene, Drug: Anastrozole, Drug: Letrozole, Drug: ExemestaneEndocrine therapy drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Anastrozole, Letrozole, Exemestane), which have been widely used in the adjuvant treatment of hormone receptor positive breast cancer. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hormone receptor-positive ductal carcinoma of the breast
Key inclusion criteria (9 listed)
- (1)Female patients aged ≥ 18 years and ≤ 85 years
- (2)The primary lesions and lymph nodes of the breast must meet all of the following conditions:
- (3)A volunteer to participate in the study and willing to cooperate with follow-up
Key exclusion criteria (4 listed)
- (1)Patients with newly diagnosed metastatic breast cancer or other malignant tumors without breast intraductal carcinoma;
- (2) Patients who have other malignant tumors before the initial diagnosis of intraductal carcinoma of the breast
- (3) Patients who have received endocrine therapy with drugs including Toremifene, Tamoxifen, Anastrozole, Letrozole or Exemestane before the initial diagnosis of intraductal carcinoma of the breast
- (4) Patients who have a serious comorbidity or other comorbidities that interfere with the conduct of the study, or those who are considered not suitable for participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen20 mg/d, oral administration | Drug | Drug Group |
| Toremifene60 mg/d, oral administration | Drug | Drug Group |
| Anastrozole1 tablet (1 mg) per day, oral administration | Drug | Drug Group |
| LetrozoleAdjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage. | Drug | Drug Group |
| ExemestaneThe recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses. | Drug | Drug Group |
Primary outcome
Disease-free survival up to 16 years
Time frame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which relevant event occurs.
Invasive disease-free survival up to 16 years
Time frame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Invasive disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which intraductal carcinoma of the breast recurs. The recurrent diseases include ipsilateral or contralateral breast cancer, local and distant recurrence of breast cancer, and death due to any reason.
Distant disease-free survival up to 16 years
Time frame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Distant disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which distant metastasis occurs.
1 secondary outcome
Overall survival up to 16 years
Time frame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Chen, MD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival up to 16 years (time frame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.